1. Field of the Invention
This invention relates to the field of strong boxes, safes, and other lockable containers, particularly those for use in ambulances and other emergency services vehicles to secure controlled substances.
2. Description of Related Art
Advanced Life Support (ALS) and air ambulance service providers are commonly required by state and federal regulatory authorities to develop, implement, maintain, and have available for review and approval by those authorities written operating procedures for procuring, storing, handling, dispensing, and disposal of all controlled substances, medications, and fluids employed in connection with those services. In particular, the security procedures submitted by a provider typically must include the provider's method of ensuring against theft; tampering with, or contamination of, controlled substances, medications, and fluids; and the identities and position titles of employees who have access to controlled substances.
Providers must be able to document the amount of each controlled substance in on-site storage, and therefore must track the distribution, disposal, and re-supply of controlled substances, medications, and fluids. Procedures for developing and maintaining such documentation must address on-site and shift change inventory procedures for all controlled substances stocked by the provider, and identify a procedure for keeping records, including inventory schedules for stocking of medical supplies and reporting and resolving any discrepancy found during an inventory.
Providers currently employ opaque narcotics storage containers manufactured of metal, plastic, or other materials. These containers may be secured from tampering by way of a numbered tamper-resistant break lock, pull-tight seal. An unbroken seal ensures that the box has not been opened, whereas any break in the seal suggests that the box may have been opened.
Because the tamper-resistant seals are easily compromised, their function is limited to providing information regarding possible tampering. In order to actually prevent unauthorized access to the controlled substances, the narcotics box is separately secured by a lock or the box itself is placed into a larger lockable storage container on or within the emergency vehicle, or both. Frequently, the storage container is rigidly secured to the vehicle, more or less permanently.
Emergency vehicles usually carry at all times standard quantities and types of controlled substances—typically, morphine, Versad, and Diazepam —in tamper-resistant glass ampules, which are stored in the narcotics container on board. Documentation procedures to track storing, handling, dispensing, and disposal of these controlled substances ordinarily will detail information about the narcotics container and the medications contained in them. This information generally includes the date and time the container was last inspected and sealed, the number of the seal, and the identity of the person who last inspected and sealed the container. Inventory information regarding the contents of the container would normally include the types, amounts, unit control numbers, and expiration dates of medications, as reflected on the labels of the ampules. Any use or disposal (e.g., due to expiration or damage) of any medications must also be documented.
When the emergency personnel on a vehicle change shifts, an individual coming on shift must confirm that the documentation generated by those coming off shift reflects properly the contents and condition of the narcotics container. Because the narcotics containers currently used by providers are opaque, the seal on a container must be broken and the container opened in order to confirm the identity of the medications in the container and their respective unit control numbers, expiration dates, and general condition. Moreover, individual ampules often must be handled physically in order to observe their respective labels and the condition of their respective tamper-resistant seals, which handling can itself lead to impairment of the integrity of the individual seals or cracking of the glass ampules and consequent loss of use of those medications. Following confirmation and documentation of the contents of the narcotics container, and replacement of any used medications, the container must be re-sealed using another numbered tamper-resistant seal. The process by which emergency medical personnel must unseal, open, and reseal narcotics containers to conduct routine, periodic drug inventories wastes time, labor, and material resources.